Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
INSYS Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00538850
First received: October 1, 2007
Last updated: January 14, 2014
Last verified: January 2014
Results First Received: May 8, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cancer
Interventions: Drug: Fentanyl sublingual spray
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
As there are dozens, if not hundreds, of cross-over sequences during the double-blind period of this study, instead of reporting participant flow for each of the cross-over sequences, participant flow is reported separately for the fentanyl and placebo groups.

Reporting Groups
  Description
Fentanyl Sublingual Spray - Titration In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
Fentanyl Sublingual Spray - Double-blind Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Placebo - Double-blind Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.

Participant Flow for 3 periods

Period 1:   Titration Period
    Fentanyl Sublingual Spray - Titration     Fentanyl Sublingual Spray - Double-blind     Placebo - Double-blind  
STARTED     130     0 [1]   0 [1]
COMPLETED     98     0     0  
NOT COMPLETED     32     0     0  
[1] There were no participants in this reporting group in the titration period.

Period 2:   Fentanyl Sublingual Spray - Double-blind
    Fentanyl Sublingual Spray - Titration     Fentanyl Sublingual Spray - Double-blind     Placebo - Double-blind  
STARTED     0 [1]   98     0 [1]
COMPLETED     0     95     0  
NOT COMPLETED     0     3     0  
[1] There were no participants in this reporting group in the double-blind period.

Period 3:   Placebo - Double-blind
    Fentanyl Sublingual Spray - Titration     Fentanyl Sublingual Spray - Double-blind     Placebo - Double-blind  
STARTED     0 [1]   0 [1]   98  
COMPLETED     0     0     95  
NOT COMPLETED     0     0     3  
[1] There were no participants in this reporting group in the double-blind period.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fentanyl Sublingual Spray Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.

Baseline Measures
    Fentanyl Sublingual Spray  
Number of Participants  
[units: participants]
  130  
Age  
[units: years]
Mean ± Standard Deviation
  55.6  ± 12.2  
Gender  
[units: participants]
 
Female     69  
Male     61  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)   [ Time Frame: Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode ]

2.  Secondary:   Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing   [ Time Frame: Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode ]

3.  Secondary:   Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing   [ Time Frame: 5 through 60 minutes after dosing for each pain episode ]

4.  Secondary:   Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing   [ Time Frame: 30 through 60 minutes after dosing for each pain episode ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Larry Dillaha, M.D., Chief Medical Officer
Organization: Insys Therapeutics, Inc.
phone: 602 910-2617
e-mail: ldillaha@insysrx.com


Publications of Results:

Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT00538850     History of Changes
Obsolete Identifiers: NCT00589342
Other Study ID Numbers: INS-05-001, CDR0000581128
Study First Received: October 1, 2007
Results First Received: May 8, 2013
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration